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1 SQGNE is made possible by the support of our sponsors: Sept 2017 Logo design: Sarah Cole Design Slide 1

2 All-volunteer non-profit with no membership dues! Supported entirely by our sponsors Over 1,400 members on LinkedIn, 945 Constant Contact More than 400 members have joined our Meetup Group Monthly meetings - Sept to June on 2 nd Wed of month SQGNE Web site: Slide 2

3 Officers / Hosts / Mission Current Officers: John Pustaver Founder Stan Wrobel President Robin Goldsmith Vice President Barbara Wioncek Treasurer David Sullivan Clerk At-large Directors: Candace Murphy Mike Arnold Jim Turner Our Gracious Host: Donna Arcand Mission To promote use of engineering and management techniques that lead to delivery of high quality software To disseminate concepts and techniques related to software quality engineering and software engineering process To provide a forum for discussion of concepts and techniques related to software quality engineering and the software engineering process To provide networking opportunities for software quality professionals Slide 3

4 SQGNE Schedule Speaker Affiliation Date Topic Joe Zec Andrew Pollner Michael Durrant Johanna Rothman Robin Goldsmith Bob Crews Mike Sowers Alexander von Zitzewitz Ed Lowry Shire Pharmaceuticals ASTQB Rothman Consulting Group, Inc. Go Pro Management, Inc Sept 13 Oct 11 Nov 8 Dec Jan 10 Checkpoint Technologies Feb 14 TechWell/SQE Training hello2morrow, Inc. Consultant Mar 14 Apr 11 May 9 Paperless software quality - why kill the forest? Why Certification? Why Choose ISTQB? Earn Big Dollar Payoffs by Assuring Usability and Accessibility Quality Testers and QA as Agile Leaders Proactive Software Quality Assurance (SQA) Overcomes SQA s Traffic Cop Resistance Test More, Test Faster, Test Continuously The New Normal for Quality and Testing in an Agile and DevOps World Revealing Invisible Technical and Architectural Debt Quality Attributes Reverse 45 Years of Obstacles to Language Related Simplification--the Biggest Opportunity to Improve Software Quality Nikhil Kaul SmartBear June 13 SOAP Testing Annual Election of Officers Slide 4

5 Tonight s Topic Paperless Software Quality why kill the forest? Joseph Zec, Associate Director, Data Systems QA & Compliance, Shire Pharmaceuticals Abstract: This case study looks at one organization s journey from a paper-based test execution system to a paperless one and how they overcame the challenges inherent in making the switch. Barriers to adopting paperless testing Planning the paperless program Communication Leveraging other efforts Training Implementation support Lessons learned Attendees will come away with a practical approach to implementing a paperless software quality system and various tips and techniques for overcoming hurdles along the way. Bio: Joe is currently Shire Pharmaceutical s Computer System Validation Lead, R&D. He and his team define and execute software development and validation strategy and policy, and monitor its effectiveness. He has over 30 years of experience in the software industry and is trained as a CMM Assessor. Most of his career has been spent in the areas of software testing and software quality assurance. He has worked in many industries, including financial services, semi-conductor test equipment, telecommunications, commercial meteorology, avionics, and medical devices. He has presented and chaired at numerous conferences, both domestically and internationally. Joe was three times named the Institute of Validation Technology s Speaker of the Year. He is also a contributing book reviewer for the Software Quality Professional publication of the American Society for Quality, and a contributing columnist for IVT s Journal of Validation Technology. A native of Massachusetts, Joe received his BA in Economics from Harvard University. Slide 5

6 Software Quality Group of New England Overcoming the Challenges of Paperless Implementation A Case Study Joseph Zec Technology QA and Compliance Lead 6Shire September 2017

7 Agenda The less there is to justify a traditional custom, the harder it is to get rid of it. Barriers to adopting paperless validation Designing the program Planning the program Implementing the program Supporting the program 7

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9 Barriers to Adopting Paperless Validation We ve always done it this way! QA doesn t trust electronic test results. We can t deal with more change right now. We don t have the time or the money. What s wrong with the current system? 9

10 Overcoming the Barriers We ve always done it this way! Without deviation, progress is not possible QA doesn t trust electronic test results. QA trust data with demonstrable integrity We can t deal with more change right now. Change is always disruptive, but change for the better can t be bad We don t have the time or the money. You d be surprised what you can accomplish with a 10 small investment

11 Overcoming the Barriers What s wrong with the current system? It s inefficient! Collecting wet ink approval signatures globally Relationships among data expressed manually Organization-wide visibility is limited Managing hand-written test results is cumbersome and error-prone Limited search and retrieval QA process flow manually enforced Review process not always well-documented 11

12 Design for Paperless Guiding principle start small Limited scope Initial target was the company s paperbased software test execution system Hand-written test results lead to issues Global distribution and collection of paper Corrections of hand-written entries Illegible handwriting Scanning paper into electronic format Storage of paper 12

13 Design for Paperless Constraints on the program No budget Had to leverage existing tools No dedicated resources Had to fit it in around existing workload Began as a bottom-up initiative There s got to be a better way 13

14 There s got to be a better way! 14

15 Design for Paperless Given the constraints, Excel was selected as the primary tool Readily available Little to no learning curve Already used for test scripts in some areas Existing document management system also leveraged Enterprise document storage solution Electronic signature functionality 15

16 Design for Paperless Test scripts written in Excel Test step #, Action, and Expected Results columns locked down and made read-only via password protection Test script approved in the DMS Tester completes Actual Results, Pass/Fail status, initials and date in Excel Executed test script entered into DMS Test script approved in the DMS 16

17 Design for Paperless Automated executed test script approval Tester signs to take accountability for test results Technical reviewer signs to attest to the accuracy of test results Quality reviewer signs to attest to the compliance of the testing activity DMS must associate roles with names DMS must provide meaning of signature 17

18 Plan for Paperless Need to plan for: Procedure updates Template development DMS Configuration Communication Training Roll-out Support 18

19 Plan for Paperless Small core project team of 5 Larger extended team of 20 Informal documentation of plan Ad-hoc team meetings Identified deliverables Sketched out timeline Solicited leadership support 19

20 Implementing Paperless Completed development work Updated procedures Created Excel test script template DMS needed no changes Created training materials Training slide deck Live demo Golden example 20

21 Implementing Paperless Chose a pilot project Communicated plans Sought agreement Performed training with project team Identified support individual Provided hyper-care on first attempts Provided early and prompt reviews Evaluated results of pilot 21

22 Implementing Paperless As a result of pilot, made some tweaks: Procedures and template Training materials Training approach Communicated progress to extended team and leadership Received go-ahead for broader roll-out 22

23 Implementing Paperless Conducted train-the-trainer session with extended team Scaled up support infrastructure Went live across most of the organization 23

24 Training By the time full-scale training started: Trainers and support personnel were highly knowledgeable Most of the bugs had been worked out of the system Live demos were well-received Golden examples became useful job aids Most users already familiar with DMS review and approval process 24

25 Communication Stressed the benefits associated with the change: Electronic review and approval Global access Enhanced visibility Elimination of hardcopy and its storage No more scanning!!! 25

26 Implementation Support Set up a group mailbox for support Published names and contact info in training materials Provided live support across time zones: India Europe USA 26

27 Questions? 27